Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-021900-93
    Sponsor's Protocol Code Number:CLIN1001PCM301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-021900-93
    A.3Full title of the trial
    Estudio europeo aleatorizado, en fase III, para evaluar la eficacia y la seguridad de TOOKAD (R) Soluble para el cancer de prostata en comparación con al vigilancia activa.
    A.4.1Sponsor's protocol code numberCLIN1001PCM301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSTEBA BIOTECH SA
    B.1.3.4CountryLuxembourg
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTOOKAD® Soluble
    D.3.2Product code WST11
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPadeliporfin
    D.3.9.1CAS number 886845-72-3
    D.3.9.2Current sponsor codeWST11
    D.3.9.3Other descriptive namePalladium Bacteriopheophorbide Monolysotaurine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeWST11 se obtiene de cultivo bacteriano. Se clasifica como un producto farmaceutico de molécula pequeña debido a las tres etapas de sintesis y purificación despues de la extracción de bacteriochlorophi
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer de prostata localizado.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
     Evaluar el impacto de la terapia FDV con TOOKAD® Soluble en la tasa de ausencia de cáncer evidente utilizando como comparación pacientes en vigilancia activa (objetivo primario A).
      
     Determinar la diferencia en la tasa de fracaso del tratamiento asociado con la progresión de la enfermedad, de cáncer de próstata de bajo riesgo a cáncer de próstata de riesgo moderado o alto, observada en pacientes sometidos a FDV con TOOKAD Soluble en comparación con los pacientes en vigilancia activa (Objetivo primario B)
    E.2.2Secondary objectives of the trial
    Determinar las diferencias entre los pacientes sometidos a FDV con TOOKAD® Soluble y
    los pacientes en vigilancia activa con respecto a:

    la tasa de terapia radical adicional par
    la carga total de cáncer en la próstata
    la tasa de acontecimientos adversos la tasa de incontinencia, disfunción eréctil, síntomas urinarios
    la tasa de acontecimientos graves relacionados con el cáncer de próstata: extensión del cáncer a T3, metástasis y muerte relacionada con el cáncer de próstata
    Se registrarán datos de calidad de vida global para futuros estudios descriptivos y de utilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los sujetos serán elegibles para la inclusión en el estudio si se cumplen todos los siguientes criterios:
    1) Cáncer de próstata de bajo riesgo diagnosticado usando: (i) dos biopsias transrectales guiadas por ecografía (TRUS): una primera biopsia y una segunda biopsia, denominada de clasificación, con una antigüedad inferior a 6 meses y usando 12 (+/ 2) cilindros, o (ii) una biopsia TRUS saturada de 1 cilindro cada 2 cm3 (hasta 24 cilindros), con una antigüedad inferior a 6 meses, y que muestra lo siguiente: adenocarcinoma de próstata con clasificación de Gleason 3 + 3 como máximo, dos (2) a tres (3) cilindros positivos para cáncer longitud máxima de afectación por cáncer de 5 mm en todos los cilindros.
    2) Estadio clínico de cáncer hasta T2a (se permite estadio patológico o radiológico de la
    enfermedad hasta T2c).
    3) Antígeno prostático específico en suero (PSA) de 10 ng/ml o menos.
    4) Volumen de la próstata superior a 25 cm3 e inferior a 70 cm3 5) Pacientes de sexo masculino a partir de los 18 años de edad.
    E.4Principal exclusion criteria
    Los sujetos no serán elegibles para el estudio si se cumple cualquiera de los siguientes riterios:
    1 ) Falta de voluntad para aceptar la asignación aleatoria a cualquiera de los dos grupos del estudio.
    2 ) Cualquier tratamiento previo o en curso para el cáncer de próstata, incluidos la cirugía, radioterapia (externa o braquiter apia) o quimioterapia.
    3)Expectativa de vida inferior a 10 años. 4 ) Cualquier afección o antecedente de enfermedad o cirugía que pueda plantear un riesgo adicional para el paciente sometido al procedimiento de FDV.
    5) Participación en otro estudio clínico o receptor de un producto de investigación en el
    mes previo a la entrada en el estudio.
    6) Sujeto incapaz de entender el documento de información para el paciente, de dar su consentimiento o completar las tareas del estudio. Sujeto bajo custodia y/o que vive en una residencia de ancianos o centro de rehabilitación.
    7) Contraindicación para estudios de IRM (por ejemplo, marcapasos, antecedentes de reacción alérgica al gadolinio o factores que no permitan la lectura exacta de IRM de la pelvis ( por ejemplo, prótesis de cadera).
    E.5 End points
    E.5.1Primary end point(s)
    Variable primaria A

    Ausencia de cualquier resultado histológico definitivamente positivo para cáncer.

    Variable primaria B Fracaso del tratamiento por la progresión del cáncer de riesgo bajo a riesgo moderado o lto durante los 24 meses de seguimieno. El riesgo moderado o alto se define como la observación de:
    Más de 3 cilindros positivos para cáncer cuando se tienen cuenta todas las exploraciones histológicas disponibles realizadas durante el seguimiento del estudio más;
    e
    o cualquier patrón de Gleason, primario o secundario, de 4 o mas;

    o al menos un cilindro afectado por cáncer mayor de 5 ml .

    o PSA >10 ng/ml (en 3 mediciones consecutivas);

    o metástasis;

    o muerte relacionada con el cáncer de próstata.

    Los cambios histológicos se evalúan por medio de biopsias TRUS de 12 cilindros o una densidad de 1 il cilindro cada 2 cm3 de tejido prostático en caso de encogimiento significativo de la próstata, realizadas a los 12 meses (+/ 2 meses) y usando biopsia TRUS saturada de 1 cilindro cada 2 cm3 (hasta 24 cilindros) a los 24 meses o cualquier otro resultado de patología, planificado o no, obtenido durante el estudio. El seguimiento se realiza hasta la pérdida del contacto con el paciente, finalización prematura del estudio o 24 meses tras la asignación aleatoria, cualquiera sea el acontecimiento del tratamiento que tenga lugar (retirada, tratamiento radical). Un grupo de profesionales cegado para el estado de exposición al tratamiento revisa los informes histfhistiológicos, ya sean positivos o negativos para cancer, de todos los pacientes y pruebas de PSA.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Active surveillance population
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 400
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 02:39:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA